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510(k) K062092

PREVU POINT OF CARE SKIN STEROL TEST by Premd, Inc. — Product Code LBS

Clearance Details

Decision
SESU ()
Decision Date
September 15, 2006
Date Received
July 24, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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